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    Manager – Clinical Trial

    Voxtur Global
    8-10 years
    Not Disclosed
    Chennai
    10 Dec. 24, 2024
    Job Description
    Job Type: Full Time Education: M.B.B.S/M.D/M.Sc/M.Pharm/Ph.D. Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Manager – Clinical Trial
    Qualifications Required: M.B.B.S/M.D/M.Sc/M. Pharm/Ph.D. (8-10 years of experience)

    Role and Responsibility:

    As a Clinical Trial Manager, you will be responsible for overseeing various stages of clinical trials, ensuring compliance with regulatory requirements, and managing the overall process for smooth trial conduct across multiple locations. Your role will involve coordination, review, approval processes, and supporting the medical and operational aspects of clinical trials.

    Key Responsibilities:

    • Protocol Preparation & Review:

      • Lead the preparation and review of synopsis for bio-study protocols.
      • Finalize protocols based on synopsis in line with SOP requirements.
      • Coordinate with IEC (Institutional Ethics Committee) and Voxtur for protocol approval.

    • Clinical Study Reports:

      • Review clinical study reports ensuring compliance with regulatory requirements.
      • Ensure study reports are reviewed by the study director, investigators, sponsors, and incorporate their feedback.
      • Submit clinical summary updates or reports for IEC approval.

    • Study Management:

      • Ensure timely initiation, smooth conduct, and on-time completion of clinical phases as per the study schedule.
      • Coordinate with the internal team and external vendors for study-related activities, including site identification and visits.
      • Conduct quality monitoring visits with Clinical Research Associates (CRAs) to ensure compliance with protocols and regulatory requirements.
      • Regular follow-ups with investigators and timely resolution of any issues that may arise.

    • Vendor and Supply Management:

      • Ensure proper reordering of trial site supplies and trial medications.
      • Manage logistics and ensure compliance with Good Clinical Practice (GCP).

    • Medical Inputs:

      • Provide medical expertise and input to the study team.
      • Facilitate site visits and review site visit reports.

    • SOP Development & Training:

      • Assist in the development and revision of Standard Operating Procedures (SOPs) for clinical trials.
      • Provide training to internal teams regarding clinical trial processes and compliance.

    • Finance and Budgeting:

      • Participate in initial finance approval processes and budgeting for trials.
      • Negotiate and finalize Clinical Trial Agreement (CTA) with vendors.

    Qualifications & Experience Required:

    • M.B.B.S/M.D/M.Sc/M. Pharm/Ph.D. with 8-10 years of experience in clinical trials or a related field.
    • Strong knowledge of clinical trial management, regulatory compliance, and GCP.
    • Excellent communication, project management, and negotiation skills.
    • Experience in coordinating with investigators, vendors, and cross-functional teams.
    • Familiarity with financial aspects of clinical trials, including budgeting and CTA negotiations.

    Skills & Abilities:

    • Strong leadership and team coordination skills.
    • Proficient in managing multiple trials and working under tight deadlines.
    • Ability to analyze and integrate data from various sources to make informed decisions.
    • In-depth knowledge of the clinical trial process from start-up to close-out.
    • Ability to provide medical expertise and input to enhance trial effectiveness.

    This role offers a great opportunity to lead and manage clinical trials in a dynamic and regulatory-compliant environment, ensuring the trials are conducted efficiently and according to the required guidelines.

    For more information or to apply, candidates can visit the organization's career page.

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